Recruiting
Phase 2

Hyperthermic Intraperitoneal Chemotherapy

Sponsor:

Mayo Clinic

Code:

NCT04858009

Conditions

Metastatic Pancreatic Carcinoma

Stage IV Pancreatic Cancer AJCC v8

Metastatic Malignant Neoplasm in the Peritoneum

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cisplatin

Hyperthermic Intraperitoneal Chemotherapy

Nab-paclitaxel

Computed Tomography

Magnetic Resonance Imaging

Study Details

Brief summary:

This phase II trial studies the effects of hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with pancreatic cancer that has spread to the internal abdominal area (peritoneal metastasis). Chemotherapy drugs, such as nab-paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. HIPEC involves "heated" chemotherapy that is placed directly in the abdomen through laparoscopic instruments, instead of through an intravenous injection. This study may help doctors determine how safe and effective HIPEC work in treating patient with pancreatic cancer.

Conditions

Metastatic Pancreatic Carcinoma

Stage IV Pancreatic Cancer AJCC v8

Metastatic Malignant Neoplasm in the Peritoneum

Study ID

NCT04858009

Start date

Feb 15, 2024

Status verified date

Dec, 2025

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age >= 18 but =< 80
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Cytologic or histologic proof of adenocarcinoma of the pancreas
  • Leukocytes >= 3,000/uL
  • Absolute neutrophil count >= 1,500/uL
  • Platelets >= 60,000/Ul
  • Serum creatinine =< 1.5 mg/dL
  • Distant metastatic disease of peritoneum may be visualized on imaging:

  • Positive peritoneal cytology
  • Limited carcinomatosis on diagnostic laparoscopy or laparotomy
  • KRASD assay positive peritoneal washings/cytology
  • Completion of preoperative systemic chemotherapy with biochemical, metabolic, and/or radiographic response defined as a reduction in the baseline CA 19-9 by > 50% or radiographic response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or metabolic response on positron emission tomography (PET)-magnetic resonance imaging (MRI) defined by PET Response Criteria in Solid Tumors (PERCIST) criteria
  • Peritoneal Carcinomatosis Index (PCI) =< 7 and surgeons deems high likelihood for a complete cytoreduction

Exclusion Criteria:

  • Distant metastatic disease not limited to peritoneum:

  • Solid organ metastases (liver, central nervous system, lung)
  • Infections such as pneumonia or wound infections that would preclude protocol therapy
  • Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence
  • Subjects deemed unable to comply with study and/or follow-up procedures
  • Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (HIPEC)

Patients undergo HIPEC with nab-paclitaxel and cisplatin over 90 minutes in the absence of disease progression or unacceptable toxicity. Patients may undergo additional HIPEC with paclitaxel and cisplatin up to 5 times. Patients undergo CT scan, MRI or PET during screening.

Interventions

Cisplatin

Given via HIPEC

Hyperthermic Intraperitoneal Chemotherapy

Undergo HIPEC with mitomycin and cisplatin

Nab-paclitaxel

Given via HIPEC

Computed Tomography

Undergo CT scan

Magnetic Resonance Imaging

Undergo MRI

Positron Emission Tomography

Undergo PET scan

Primary outcome measure

  • Overall survival [ Time Frame: Up to 4 years ]
  • Progression-free survival [ Time Frame: Up to 4 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Summer L. Auerbach

507-422-9153Auerbach.Summer@mayo.edu

Principal Investigator:

Cornelius A. Thiels, DO, MBA

More Information

Sponsor

Mayo Clinic

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-12-16.